Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms

NCT ID: NCT05315856

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

Brief Summary

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Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity

Detailed Description

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There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.

Conditions

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COVID-19 Vaccination Inflammation Vaccine Immune Response Vaccine Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ChAdOx1 vaccine group

AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL \[5 × 1010 viral particles\] per dose)

either BNT162b2 or ChAdOx1 vaccine

Intervention Type BIOLOGICAL

Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.

BNT162b2 vaccine group

Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL \[30 μg\] per dose)

either BNT162b2 or ChAdOx1 vaccine

Intervention Type BIOLOGICAL

Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.

Interventions

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either BNT162b2 or ChAdOx1 vaccine

Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
* healthy adults without underlying medical condition

Exclusion Criteria

* Volunteers who had ever infected with SARS-CoV2 were excluded.
Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Korean Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joon Young Song

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon Young Song, MD

Role: STUDY_CHAIR

Korea University Guro Hospital

Jung Yeon Heo, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Yu Bin Seo, MD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Kangnam Sacred Heart Hospital

Locations

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Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon Young Song, MD

Role: CONTACT

+82226263052

Jung Yeon Heo, MD

Role: CONTACT

+82312197818

Facility Contacts

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Jung Yeon Heo

Role: primary

Yu Bin Seo

Role: primary

Joon Young Song

Role: primary

Other Identifiers

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2021GR0099

Identifier Type: -

Identifier Source: org_study_id

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